Human Hand Mimetic and Pediatric Bolster Support System Device

ABSTRACT

A human hand mimetic and pediatric support system device to provide comfort, positioning aid, sense of security and support for infants, especially premature infants or other users lacking full mobility. This device consists of a cavity in the shape of a human hand (glove/mitten) partially or totally filled with a freely flowable material and closed at the cuff. An optional extension to the cuff mimics an arm/forearm to provide extra length, weight and/or flexibility of usage. This device provides continual gentle pressure and subtle restraint by mimicking the touch of a human hand and conforming to the contour of the body. The device may be used directly touching the skin, is washable without disassembly, and it does not interfere with medical or other equipment. It may be used under or over the body of the infant (excluding the face) or to secure external items in place such as pacifiers, bottles, paperwork, toys, tubes, etc.)

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of Ser. No. 10/414,518 for a “Humanhand mimetic and pediatric bolster support system device” which wasoriginally filed on Apr. 15, 2003, claiming priority from provisionalapplication Ser. No. 60/374,296 (filed Apr. 22, 2002) (“Human handmimetic device”) and also claiming priority from provisional applicationSer. No. 60/383,932 (filed May 30, 2002) (“Pediatric Bolster SupportSystem”). This application incorporates by reference all priordisclosures referenced in this paragraph.

STATEMENT REGARDING FED SPONSORED R&D

Not Applicable

REFERENCE TO SEQUENCE LISTING, A TABLE, OR A COMPUTER PROGRAM LISTINGAPPENDIX

Not Applicable

BACKGROUND OF THE INVENTION

This invention relates to a device to provide comfort, positioning aid,sense of security and support for infants, especially premature infantsor other users lacking full mobility. It provides continual gentlepressure, aid in positioning, and subtle restraint by mimicking theshape/weight of a static human hand and providing an optional extensionthat may be converted to a pediatric bolster support system device.

The caregiver of premature and term infants must determine the positionthat is more comfortable for the infant given his/her specific situationand medical condition. At the present, there are a variety of devicesthat are currently used to assist on the comfort of infants:

Positional aids: Nurses use different elements to secure the position ofthe infant and/or the medical equipment and other items both touchingthe infant as well as away from him, i.e., they tape the items to anearby blanket and/or to a small stuffed animals to secure the positionof the medical equipment (i.e., tubes, cables, etc) and other devices(i.e., pacifiers, blankets, paperwork, etc.)

Support: Towels, blankets, cloth diapers and even t-shirts are rolled togive support and assist on positioning the infant while laying orsitting down. These devices are made out of cloth and they are soft andflexible thus they do not provide sufficient support, they also canunroll easily.

Sense of security: caregivers often “swaddle” infants in towels orblankets to give them some support and boundaries, in addition, someplace light and small stuffed animals over the infants (on the chest orbelow and/or on the back of the head) when they cannot use their ownhands to offer continual gentle pressure to their patients. However,these items do not conform to the body and may be too light defeatingthe purpose of its use. Currently, it is common to see 1 to 5 infantsfor each nurse and the nurses can not use their own hands to giveconstant support or restraint.

None of these devices above are made for the purpose mentioned;moreover, they do not conform to the infant's bodies and while notserving the purpose well, they may be unsafe by creating a suffocationhazard and also may interfere with hospital equipment such as tubes,cables, etc. Moreover, the items that are rolled (towels, t-shirts, etc)may unroll and not provide the support needed; and, the families of theinfants, for the most part, must provide the stuffed animals, so notevery infant has one to use for comfort.

The human hand mimetic and pediatric bolster support system device ofthis invention provides the intended use of all the devices mentionedabove by assisting as:

Positional aid: by providing boundaries and the ability to use thedevice on top/under/around or away from the body when laying in anyposition or sitting up, or by assisting with positioning and securingexternal elements such as medical equipment (tubes, etc), blankets,pacifiers, etc.

It provides support by preventing rolling of the infant by applyingpressure to any body part (except the face) while in prone position(i.e., on top of the back, legs, back of the head, etc, or under thestomach, etc.) or supine position (i.e., under the head, or under or ontop of arms, legs, etc.) or sideling (i.e., on the back of the head, oron top of the hip, as back support, on or between the legs, etc.). Thedevice also may include and extension to the cuff to simulate anarm/forearm to give extra support by increasing the volume andmaintaining the density. In addition, this extension may be converted tobe a pediatric bolster support system by shifting and securing thepellets to the extension's side and making its density 100%, that way,the extension becomes harder, less flexible and heavier, providing extrasupport to the infant. This device, when converted to the pediatricbolster system, may not be placed over the infant as it does not totallyconform to the shape of the body and it may be too heavy for prematureinfants.

Sense of security: to the infant by placing it fully or partially overthe body (except the face), giving the sense of being touched andaccompanied. It conforms to the body and is sufficiently heavy toprevent slipping. It can be used safely in any environment, isconvenient, practical, washable without disassembly, and it isinexpensive, giving the possibility to provide one device for eachinfant minimizing potential contamination due to sharing of devicesamong infants. It also gives a sense of comfort for the infant's familyas the shape of the device is appealing and familiar to them byresembling their own hands that stay with the infant while they cannotbe with him/her. At the end of the hospitalization, the family may takethe device home with them and use it for support in the car seat duringtransportation.

Many products have been developed to assist infants, including U.S. Pat.No. 5,996,152 of Wilson (1999). In that patent, the sleep promoting andcomforting device for infants uses clips that may not be suitable forpremature infants in the Neonatal Intensive Care Unit (NICU) as many ofthe premature infants in incubators or warmers do not wear clothing.Moreover, the use of clams and rod-like structures and the device thatcovers a great deal of the infant's body may interfere with hospitalequipment/devices such as warmers, IVs, tubes, etc. In addition,different sizes of the device must be made to fit the different infantsizes. A device that can be used not only for term newborn infants butfor premature infants as well and one that does not require differentparts that may malfunction or interfere with medical devices will bedesirable.

Further, U.S. Pat. No. 6,161,239 of Grazel (2000), the infantpositioning device must be made to fit the weight and height of theinfant as the elongated sleeve is used to surround or wrap about theinfant, therefore, different sizes of the device must be provided to fitinfants of different sizes, i.e., for those weighing 2 pounds or less upto those weighing 7 lbs or more. Moreover, this device is not to beplaced on top of the infant but surrounding him/her. It would bepreferable that the same size device could be used on different sizeusers and for its design to allow it to be placed on top, under, awayand by the infant to provide flexibility of use and provide sense ofsecurity, aid in positioning, support and comfort.

Likewise, the following patents disclose devices that provide infantsupport and/or comfort: U.S. Pat. Nos. 4,538,310 (Scott, 1985),4,783,865 (Stotler, 1988), 5,048,136 (Popitz, 1991), 5,014,376 (Doran etal), 5,272,780 (Clute, 1993), 5,375,278 (VanWinkle, 1994), 5,581,832(Bridley, 1996), 5,499,418 (Tan, 1998), and 5,988,752 (Richards, 1999).None of these devices are used to be placed on top of the infant butbelow or besides him/her. Moreover, none of the devices in these patentsmay be used to combine comfort, positioning aid, support and a sense ofsecurity for the user.

BRIEF SUMMARY OF THE INVENTION

This invention is a device used to provide comfort, sense of securityand support for infants and other users by mimicking a human hand andproviding a pediatric bolster support system device. The inventioncomprises a cavity with the shape of a human hand (glove or mitten) andmay also include an optional appendage or extension to the cuff to mimica forearm/arm to form a pediatric bolster support system device toprovide ease of positioning, extra weight or support. Both the hand andthe extension may be partially or fully filled with a freely flowablematerial and may have the capacity to conform to the contour of theinfant and provide adequate subtle and continuous pressure to mimic ahuman hand. It also gives a sense of comfort for the infant's family asthe shape of the device is familiar as it mimics their own hands thatstay with the infant while they cannot be with him/her.

The sack or cavity is made of a soft and fully washable material and maybe safely placed directly on the infant's skin. Contained within thecavity is any free flowable material although it is recommended the useof pellets of a material such as polyethylene that is washable and inertto fluids, medicines, or other materials that may be spilled on thedevice.

It may be used under/over/by any part of the body excluding the face ofthe infant to prevent suffocation, and, while lying down in any position(prone, supine, and sideling) or sitting up. In hospitals and at homecare, it can be used without interfering and even securing medicalequipment such as tubes, and other equipment.

The device is washable without disassembly, and may also be used tosecure external objects in place such as pacifiers, blankets, papers,toys, tubes, monitor probes, and other hospital or home devices by theweight of the device or using a tying mechanism found at the end of thedevice. The hand and/or the extension may contain internal or externalapparatus such as a vibrator, warmer, rattle, music/message player, etc.In all hospital units, such as cancer units, intensive care units, andat any place, the device assists on giving the patients a sense of beingtouched and comforted by someone while they lack full mobility;moreover, the size of the user is unimportant.

Accordingly, several objects and advantages my HUMAN HAND MIMETIC ANDPEDIATRIC BOLSTER SUPPORT SYSTEM DEVICE are:

1. To provide a device that will provide continual gentle pressure andsubtle restraint to the user by mimicking a human hand

2. To promote rest and sleep to the user by soothing, providingboundaries and a sense of being accompanied.

3. To assist on the comfort and safety of the premature infant childseat, strollers, etc., by placing it on the sides of the infant toprevent movement or shifting while restrained.

4. To provide a device to be used in any place, including hospitals,daycares, car seats, at home, etc.

5. To assist patients while they remain hospitalized or at home, withoutinterfering with medical equipment.

6. To provide a device that is safe, small, light weight, convenient,transportable, washable without disassembly, easy to use, that may beused directly on the skin and at the same time it is effective andaffordable

7. To provide a device that is affordable to hospitals, contributingorganizations or individuals so each infant may be the owner of his/herown device and take it for use at home minimizing the risk ofcontamination by sharing.

8. To give support and gentle pressure to the infant while performingactivities such as massages, playing times, therapy, etc.

9. To provide extra uses if it contains optional internal or externalapparatus such as a vibrator, warmer, rattle, music/message player, etc.

10. The ability to convert the device to a pediatric bolster supportsystem device by shifting the filling to either side to increase thedensity volume to 100% and securing it with a tying mechanism. Thedensity volume of the hand and forearm/extension sides of the device maybe made heavier/lighter, hard/soft, and be used as a pediatric bolstersupport system device when the density volume is increased to 100%.

11. To give the flexibility to be used on any lying position andover/under/away from the infant:

a. Under the infant—as a pillow, neck roll, leg support under the knee,to raise the head or body, between the legs while sideling, under thestomach while in prone position, etc.

b. Over the infant—mimicking a human hand touching back of the headwhile immobilized, over the hips, arms, legs, buttocks or other bodypart except the face. When the device is converted to a pediatricbolster support system device it is discouraged to use it over prematureinfants as it does not conform to the body and it may be too heavy.

c. By or around the infant—as back support to prevent roll-overs, ashead support to prevent the child from moving it to the back, around theinfant to provide boundaries, used to secure objects like pacifiers,etc.

d. Away from the infant—as a weight or securing other objects such aspaperwork, blankets, or medical equipment like tubes, monitor probes,etc.

12. To provide a comfort item to children that is safe and familiar tothe user and caregivers

13. To prevent/eliminate odors when filled partially with deodorizingpellets.

14. To assist on aromatherapy if partially filled with scented pellets.

15. To assist patients of any size that lack full mobility.

16. The shape of the device resembles a human hand and it is appealingand familiar to the user, the caregiver and their families and may bemade of different sizes

17. Because of the flexible nature of the materials, the device willcontour the surface where is placed on making the size of the userunimportant.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a perspective view of the human hand mimetic device of thepresent invention; Part 1 is the sack in shape of a hand, part 2 is theseam that shuts the cavity at the end of the device, and Part 3 a at thecuff is the optional piece of material that serves as a string that maybe used to assist on securing external devices and/or hanging the devicefor storage

FIG. 2 shows part 1, 2 and 3 a of FIG. 1, and part 4 is the freelyflowable material that is the content of the cavity. The device may befilled partially or fully.

FIG. 3 shows the hand shaped cavity (Part 1), the seam (Part 2), the tiemechanism (Part 3 a), the freely flowable material (Part 4) and Part 5is the optional and permanent extension to the cuff that mimics thearm/forearm with an additional optional string (part 3 b) at the seam.This extension forms a pediatric bolster support system device as thevolume density of either side (hand-part 1 or forearm-part 5) may becontrolled by using part 3 a to tie it around the device at the cuffpreventing the shifting of the pellets (part 4). Part 5 resembles a longcuff or sleeve.

FIG. 4 shows an infant with the pediatric bolster support system deviceof this invention being used while sideling. The string (part 3 a) isused to secure the increased volume density of the extension (part 5) to100% to provide extra support. Note the “hand” (part 1) is almost emptyof pellets (part 4) as they were shifted to the extension side andsecured with part 3 a.

FIG. 5, shows the human hand mimetic device (part 1, 2 and 3 a) withoutthe extension (part 5) placed on top of the child while sideling to givehim continual gentle pressure and subtle restraint and boundaries. Thedevice may also be used over or under any part of the body except theface (i.e., back of the head, back, legs, stomach, etc) while laying inany position or sitting up.

FIG. 6 shows an external object, this case a pacifier, being secured andpositioned by pediatric bolster support system device. In this case, thestring (part 3 a) at the cuff is used to secure the increase of thevolume density of the extension (part 5) by decreasing it at the hand(part 1). As other option, the “fingers” of part 1 may also be used toassist with positioning when the volume density is increased in the handside (part 1) of the device and decreasing it at the extension (part 5)side of the device and securing it by tying the string (Part 3 a) aroundthe device. The optional string at the cuff (part 3 a) may also be usedto secure external items.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 shows a perspective of the human hand mimetic device (part 1)constructed in accordance with the present invention. As can be seen,the device resembles a human hand, where the part 1 is of the shape of ahand or glove. The recognizable shape of the hand provides a sense ofcomfort for the infant's relatives as it mimics their own hands thatstay with the infant while they cannot be with him. It also mimics theweight and comforting touch of the hands of the caregiver.

The material is washable and may be in direct contact with the sensitiveskin of the infant, such as a smooth 100% cotton or 100% polyester toprevent marking the skin of the infant. The seam (part 2) closes thecavity at the end of part 1; FIG. 1 shows it 2 cms from the end of thedevice. Part 3 a is the optional tying mechanism, for example astring-like that is used to assist on securing external devices or tostore by hanging it. This string is made of 100% cotton or 100%polyester, a soft, washable material that allows easy tying/untying andthe length 30 cms attached to the device at the middle of the string bythe seam (part 2). The caregiver to ensure the safety of the child andprevent choking may shorten this length.

Now turning to FIG. 2, there is shown the flowable material (part 4),preferably a material such as pellets that is washable and inert tofluids, medicines, or other materials that may be spilled on the device.In addition, the material should provide sufficient weight to offersupport and subtle restraint. It may comprise a polymeric plasticcomposition and in the preferred embodiment, the composition is of ahigh-density polyethylene (HDPE). Also, the pellets (part 4) may besmooth and spherical with about one-eighth to one-quarter of an inch ofdiameter. Other shapes may be used, yet, their size should beequivalent. It may also be filled partially with deodorizing pellets toprevent/eliminate odors, or with scented pellets to assist onaromatherapy and use in other environments.

Together with the type of material, the fill density of the cavity isimportant. The fill density and pliability are given by the amount ofpellets inside the cavity. It should be filled so that the cavity isflexible, it gives enough support and restraint and can be used over aninfant. That is, between 100 and 300 grams to resemble the human handweight, or filled between 60% and 80% of the capacity of the cavity.

FIG. 3 shows the hand shaped cavity (Part 1), the seam (Part 2), thefreely flowable material (Part 4) and Part 5 that is the optionalextension that mimics the arm/forearm that may be converted into thepediatric bolster support system device. This extension provides thedevice with extra room for more pellets to provide more weight and morearea of support by retaining the density and increasing the volume. Ifthe extension (part 5) is used, the size recommended is 25 cm of lengthand 5 cm of diameter. The seam at the end of the extension may be astraight seam to make a flat end, as shown in part 2, or one that makesthe end round or circular, square, rectangular, etc, to eliminate theedges of the flat end.

The weight of the device will increase but the density volume remains60-80% of the total cavity. If the extension is made, an extra string(part 3 b) is provided. Both strings (part 3 a and 3 b) may be used tosecure external items to the device or to hang the device for usageand/or storage. The string at the cuff (part 3 a) is also used to tie itaround the cuff to secure the volume density of either side of thedevice according to the user's preferences and needs. As the densityvolume of one side (part 1 or part 5) increases by shifting the pellets(part 4), the other side is decreased. By increasing the density, thatside of the device becomes heavier, fuller, less flexible and may beused as a bolster support system device for extra-support. By decreasingthe density, the side becomes flatter, lighter and more flexible. Thestring at the cuff (part 3 a) is tied around the cuff to secure volumedensity of either side of the device (the hand/part 1 or the forearmextension/part 5). The device may be used under or over any part of thebody excluding the face of the infant, and, while lying down in anyposition (prone, supine, and sideling).

Now turning to FIG. 4, it shows an infant in the sideling position withdevice converted to the pediatric bolster support system device of thisinvention. In this use, the extension (part 5) lies directly on the backof the infant providing support to avoid rolling over. The volumedensity of the forearm (extension—Part 5) is increased to 100% byshifting all the pellets to the forearm/extension section and tying thestring (part 3 a) around the cuff to secure it. This allows the deviceto get heavier, decrease flexibility and provide extra support. In thiscase, the “hand” side (part 1) is almost empty of pellets. It isdiscouraged to use the device over a premature infant when it isconverted to the pediatric bolster support system device, as it does notconform to the shape of the body and may be too heavy for the tinyinfants creating a possible safety hazard.

In FIG. 5, the device is placed on the top of the child while sidelingto provide comfort. In this figure, the device does not include theextension (part 5). In hospitals it can be used without interfering withmedical equipment such as tubes, monitor probes, warmers, incubators,ventilators, and other equipment. Because of the flexible nature of thematerials, the device will contour the surface where is placed on makingthe size of the user unimportant.

Lastly, FIG. 6 shows the device converted to the pediatric bolstersupport system device holding an external object, this case a pacifier.It is tied and secured by the string (Part 3 b) at the end of theextension (part 5). Also, to convert into the pediatric bolster supportsystem device, the string at the cuff (Part 3 a) secures the pellets inthe extension side (part 5) of the device to increase the volume andmake it less flexible to be able to support the pacifier. As otheroptions, the “fingers” of Part 1 and the string at the cuff (Part 3 a)may also be used to assist with positioning/securing of items. Thedevice may also be used as a weight, near or away from the infant, tokeep blankets, toys, and/or other devices such as medical equipment inplace (i.e., tubes, IVs, ventilators, monitor and other cables, etc).

It is explicitly stated that the claimed device is not limited to theexplanation of the chosen alternatives but encompasses othermodifications/alterations within the scope of this ingenious concept.

Original claims to the parent application disclosed: (1) a flexibledevice with a cavity of a shape of a human hand (glove or mitten), thatprovides comfort, support, positioning aid and sense of security toinfants, especially those born prematurely. This cavity has apredetermined fill density to allow flexibility and contour of the bodyof the infant. The material of the filling is high-density polymerpellets and the cavity's is a soft, washable material that may be incontact with the skin of the infant; (2) a comfort, positioning aid,support and sense of security device as defined in claim 1 wherein thecomposition of said pellets is high density polyethylene (HDPE); (3) acomfort, positioning aid, support and sense of security device asdefined in claim 1 wherein the material of the cavity is a soft, smooth,washable material such as 100% cotton or 100% polyester fabric; (4) acomfort, positioning aid, support and sense of security device asdefined in claim 1 wherein the fill density of pellets comprises 60 to80% of the total cavity; (5) a comfort, positioning aid, support andsense of security device as defined in claim 1 wherein the weight of thepellets may range from 100-300 grams; (6) a comfort, positioning aid,support and sense of security device as defined in claim 2 where saidpellets are spherical in shape and about 1 to 3 mm in diameter; (7) anoptional extension to the device as defined in claim 1 that increasesthe length of the cuff by 25-30 cms to mimic a forearm/arm or sleeve.This extension increases the volume and weight of the device keeping thesame fill density of claim 4 and increasing the weight of claim 5. Thissleeve potentially converts into a pediatric bolster support systemdevice; (8) an optional tying mechanism added to the device as definedin claim 1 where said tying mechanism is a string at the cuff and at theend of the “extension” as defined in claim 7. These strings of 25-30 cmsof length are placed to secure external items, to store the device byhanging it, or to secure the pellets (as defined in claim 4) in eitherside of the device (the hand and the extension) to modify the volumedensity of both sides.

1. A method of using the hand mimetic and pediatric support systemdevice of claim 25 comprising the steps of: (a) Securing an infant in aprone resting position with head turned sideways; (b) Placing the lengthof said device over an infant; (c) Ensuring that device extends andcontours over the hips, buttocks, and back of the infant; (d) Wherebythe infant is provided, boundaries, support and the comfort and weightof a human hand on his or her back.
 2. A method of using the handmimetic and pediatric support system device of claim 25 comprising thesteps of: (a) Securing an infant in a prone resting position with headturned sideways; (b) Placing a hand shaped cavity of the device over thehips and buttocks of said infant; and, (c) Whereby the infant isprovided support and the comfort and weight of a human hand on his orher backside.
 3. A method of using the hand mimetic and pediatricsupport system device of claim 25 comprising the steps of: (a) Securingan infant in a resting position on his or her side; (b) Wrapping thelength of a hand shaped cavity and an extension of the device around theinfant, so that said hand shaped cavity rests next to the infant's headand said extension extends the length of the infant's back; and, (c)Whereby the position of the infant is stabilized and rollovers of theinfant are prevented.
 4. A method of using the hand mimetic andpediatric support system device of claim 25 comprising the steps of: (a)Securing an infant in a resting position on his or her side; (b) Placingan extension of the device between the legs of the infant as a pillow;and, (c) Whereby the infant remains in a more natural posture providingcomfort, boundaries, and a sense of security.
 5. A method of using thehand and mimetic and pediatric support system device of claim 25comprising the steps of: (a) securing an infant in a supine restingposition; (b) placing said device beneath the infant's head as a pillow;and, (c) whereby the infant's head is maintained in a safe andcomfortable position without compromising the spine.
 6. A method ofusing the hand mimetic and pediatric support system device of claim 25comprising the steps of: (a) securing an infant in a prone restingposition; (b) placing said device beneath the infant's stomach so thedevice is perpendicular to the infant; and, (c) whereby the infant'sposition is maintained for the safety and comfort of the infant.
 7. Amethod of using the hand mimetic and pediatric support system device ofclaim 25 comprising the steps of: (a) securing an infant in a sittingposition; (b) placing at least one device on at least one side of saidsitting infant so that the length of said device is parallel to thelength of and touching said infant; and, (c) whereby the infant isprovided support to remain upright, and assisting a correct posture byprotecting the spine against unnecessary lateral movements.
 8. A methodof using the hand mimetic and pediatric support system device of claim25 comprising the steps of: (a) Identifying loose items near an infantand incubator; (b) placing the length of said device over loose items inan infant bed; and (c) whereby said loose items are secured within saidincubator and do not get tangled with said infant.
 9. A method of usingthe hand mimetic and pediatric support system device comprising thesteps of: (a) manipulating said device so that freely flowable materialis moved from a hand shaped cavity into and confined in an extension(that mimics an arm) of said device; (b) placing said extension of saiddevice lengthwise along the length of an infant from a top of saidinfants head, down along said infant's spine; and, (c) whereby unwantedmovement of the infant's head is restricted, which is particularlyuseful during infant intubations and to prevent against unintended tuberemoval.
 10. A method of using the hand mimetic and pediatric supportsystem device of claim 25 comprising the steps of: (a) Securing aninfant in a supine resting position; (b) Wrapping the length of a handshaped cavity and an extension of the device around at least one side ofthe infant; (c) whereby the infant is provided support and boundaries.